Trial Outcomes & Findings for Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients (NCT NCT02643862)

NCT ID: NCT02643862

Last Updated: 2018-01-12

Results Overview

Proportion of food allergic (FA) participants who pass a DBPCFC to 2,000 mg protein for each of 2 allergens at week 36. Xolair arm: 30/36 (83.3%) Placebo arm: 4/12 (33.3%)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: 36 weeks
• Results posted on: 2018-01-12

Participant Flow

Participant milestones

Measure	Xolair Pts will be randomized to receive xolair at a 3 active:1 placebo ratio Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria	Placebo This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria
Overall Study STARTED	36	12
Overall Study COMPLETED	36	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients

Baseline characteristics by cohort

Measure	Xolair n=36 Participants Pts will be randomized to receive xolair at a 3 active:1 placebo ratio Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria	Placebo n=12 Participants This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	36 Participants n=5 Participants	12 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	8 years n=5 Participants	7 years n=7 Participants	8 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	6 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	6 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	12 participants n=7 Participants	48 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 weeks

Population: this is an ITT population

Proportion of food allergic (FA) participants who pass a DBPCFC to 2,000 mg protein for each of 2 allergens at week 36.

Xolair arm: 30/36 (83.3%) Placebo arm: 4/12 (33.3%)

Outcome measures

Measure	Xolair n=36 Participants Pts will be randomized to receive xolair at a 3 active:1 placebo ratio Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria	Placebo n=12 Participants This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria
Desensitization Measured by Proportion of Food Allergic (FA) Participants Who Pass a DBPCFC to 2,000 mg Protein for Each of 2 Allergens at Week 36	30 Participants	4 Participants

SECONDARY outcome

Timeframe: 36 weeks

Population: We analyzed an ITT

Proportion of FA participants who pass a DBPCFC to 4,000 mg each of 2 allergens at week 36.

Greater than 3 foods at 36 weeks for

Xolair: 21/26 (80.8%) Placebo: 2/7 (28.6%)

Outcome measures

Measure	Xolair n=26 Participants Pts will be randomized to receive xolair at a 3 active:1 placebo ratio Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria	Placebo n=7 Participants This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria
Desensitization Measured to Increased Doses Measured by Proportion of FA Participants Who Pass a DBPCFC to 4,000 mg Each of 2 Allergens at Week 36	21 Participants	2 Participants

Adverse Events

Xolair

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Xolair n=36 participants at risk Pts will be randomized to receive xolair at a 3 active:1 placebo ratio Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria	Placebo n=12 participants at risk This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair Xolair: Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria
Skin and subcutaneous tissue disorders urticaria	91.7% 33/36 • Number of events 106 • AEs were collected over the entire course of the active study The same definitions of AE and SAE were used as per clinicaltrials.gov	100.0% 12/12 • Number of events 28 • AEs were collected over the entire course of the active study The same definitions of AE and SAE were used as per clinicaltrials.gov

Additional Information

Dr. Kari Nadeau

Stanford

Phone: 650-867-4592

Email: knadeau@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place